Locally Advanced Rectal CancerPhase 2NLCCRIT-LARCNCT06493240
Neoadjuvant Long-course Chemoradiotherapy Followed by Immunotherapy for Locally Advanced Mid-low Rectal Cancer
A Phase 2 study testing radiation, PD-1 Monoclonal Antibody and TME surgery in people with Locally Advanced Rectal Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this study was to evaluate the effect of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) in patients with locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- radiation, PD-1 Monoclonal Antibody and TME surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18~75
- ECOG score 0~2
- biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge
- no distant metastasis, staged II/III (T4b excluded) by MRI
- maximum diameter of rectal cancer lesion≥10mm according to baseline CT or MR
- willing and able to comply with study protocol
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- consent to the use of blood and tissue specimens for study
- no history of previous anti-tumor treatment (e.g. radiation, chemo, immuno, bio, herbal, etc.)
- no disorders/diseases of immune system (e.g. systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, hyperthyroidism/hypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.)
- no significant dysfunction of major viscera (e.g. heart, lung, liver, kidney, etc.)
- no jaundice or gastrointestinal obstruction
- no acute/ongoing infection
- no significant irregularities in blood routine test and biochemical test results, particular requirements include: neutrophils≥1.5×109/L, HGB≥80g/L, platelet≥100×109/L, serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, ALT、AST≤2.5×ULN
- no social or mental disorder
- for women of child-bearing age, a negative result of serological pregnancy test is required, and effective contraception measures from inclusion till 60 days after the last dose of study drug is required
Who cannot join
- multiple cancers, or with concomitant malignant tumors besides rectal cancer
- having received any anti-cancer treatment (surgery, drugs, etc.) in the past 5 years
- history of recent major surgery
- with condition that affects the absorption of capecitabine via gastrointestinal tract (e.g. inability to swallow, nausea, vomiting, chronic diarrhea, etc.)
- with uncontrolled, severe, concomitant diseases of any sort
- allergic to any of the ingredients under study
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- estimated survival ≤ 5 years due to any reason
- preparing for or having previously received organ or bone marrow transplant
- having received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to inclusion
- for patients with history of disorder of central nervous system, investigator discretion is required as to whether the clinical severity prevents the signing of informed consent or affects the patient or oral medication compliance
- with other conditions/issues that may affect the study results or cause the study treatment to be terminated halfway (e.g. alcoholism, drug abuse, etc.)
- pregnant or lactating women, or women intending on conception during treatment period
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Neoadjuvant Long-course Chemoradiotherapy Followed by PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer
The purpose of this study was to evaluate the effect of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) in patients with locally advanced rectal cancer.
Read the detailed description
Investigator designed a single-arm, open-label, phase II trial and the purpose of this study is to observe and evaluate the efficacy and safety of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) for locally advanced rectal cancer.Participants will accept capecitabine-based long-term radiotherapy(50.4Gy radiation) followed by 200mg Sintilimab each time for 3 times, with 2-week intervals. The primary endpoint is pCR rate, and secondary endpoints include sphincter-preserving rate, adverse event rates.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- radiation, PD-1 Monoclonal Antibody, TME surgery
- Keywords
- Locally Advanced Rectal Cancer, PD-1 inhibition, neoadjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiationRadiation
45 Gy radiation dose in 25 fractions to the pelvis
PD-1 Monoclonal AntibodyDrug
Also called Sintilimab
200mg Sintilimab after radiation (3 times, 2-week interval)
TME surgeryProcedure or surgery
Also called radical proctectomy
TME surgery for 6~8 weeks after radiation
| Study group | Role | What they receive |
|---|---|---|
| nCRT+PD-1 | Experimental | Long-course chemoradiation followed by PD-1 inhibition (Sintilimab 200mg, 3 times, 2-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 6 weeks after completion of radiation. Receives: Radiation: radiation; Drug: PD-1 Monoclonal Antibody; Procedure: TME surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
pathological complete response rate
Measured: within 1 week after surgery
Secondary outcomes (4)
sphincter preserving rate
proportion of patients with preserved anal sphincter
Measured: instantly after surgery
immune-related adverse event rate
adverse event rate that is deemed to be associated with PD-1 inhibition
Measured: from commencing of PD-1 inhibition to the 30th day after surgery
treatment-related adverse event rate
adverse event rate that is deemed to be associated with all treatments
Measured: from commencing of treatment to the 30th day after surgery
incidence rate of surgical complications
incidence rate of surgical complications within 30 days after surgery
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Jan 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Zhanlong, Peking University People's Hospital
- Investigators
- Zhanlong Zhanlong, M.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493240
- Sponsor's protocol ID
- 2023PHB222
- Other IDs
- Z220014
- Acronym
- NLCCRIT-LARC
- Status last verified
- Apr 2025
- First submitted
- 2 Jul 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Export of individual patient data is a sensitive issue according to current Chinese laws
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Long-course Chemoradiotherapy Followed by PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer
- ClinicalTrials.gov ID
- NCT06493240
- Acronym / sponsor ID
- NLCCRIT-LARC / 2023PHB222
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- Locally Advanced Rectal Cancer, PD-1 inhibition, neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the effect of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) in patients with locally advanced rectal cancer.
Detailed description
Investigator designed a single-arm, open-label, phase II trial and the purpose of this study is to observe and evaluate the efficacy and safety of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) for locally advanced rectal cancer.Participants will accept capecitabine-based long-term radiotherapy(50.4Gy radiation) followed by 200mg Sintilimab each time for 3 times, with 2-week intervals. The primary endpoint is pCR rate, and secondary endpoints include sphincter-preserving rate, adverse event rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nCRT+PD-1 | Experimental | Radiation: radiation, Drug: PD-1 Monoclonal Antibody, Procedure: TME surgeryLong-course chemoradiation followed by PD-1 inhibition (Sintilimab 200mg, 3 times, 2-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 6 weeks after completion of radiation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- aged 18~75
- ECOG score 0~2
- biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge
- no distant metastasis, staged II/III (T4b excluded) by MRI
- maximum diameter of rectal cancer lesion≥10mm according to baseline CT or MR
Key exclusion criteria (12 listed)
- multiple cancers, or with concomitant malignant tumors besides rectal cancer
- having received any anti-cancer treatment (surgery, drugs, etc.) in the past 5 years
- history of recent major surgery
- with condition that affects the absorption of capecitabine via gastrointestinal tract (e.g. inability to swallow, nausea, vomiting, chronic diarrhea, etc.)
- with uncontrolled, severe, concomitant diseases of any sort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation45 Gy radiation dose in 25 fractions to the pelvis | Radiation | nCRT+PD-1 |
| PD-1 Monoclonal AntibodyAlso: Sintilimab200mg Sintilimab after radiation (3 times, 2-week interval) | Drug | nCRT+PD-1 |
| TME surgeryAlso: radical proctectomyTME surgery for 6~8 weeks after radiation | Procedure or surgery | nCRT+PD-1 |
Primary outcome
pCR rate
Time frame: within 1 week after surgery
pathological complete response rate
4 secondary outcomes
sphincter preserving rate
Time frame: instantly after surgery
immune-related adverse event rate
Time frame: from commencing of PD-1 inhibition to the 30th day after surgery
treatment-related adverse event rate
Time frame: from commencing of treatment to the 30th day after surgery
incidence rate of surgical complications
Time frame: within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No. Export of individual patient data is a sensitive issue according to current Chinese laws
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhanlong Zhanlong, M.D. principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiation, PD-1 Monoclonal Antibody and TME surgery in people with Locally Advanced Rectal Cancer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: within 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.